A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Systemic Juvenile Idiopathic Arthritis

Treatments: Drug: Baricitinib; Drug: Tocilizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04088396

I4V-MC-JAHU (Other Identifier)

2023-507883-38-00

16275

2017-004495-60 (EudraCT Number)

Details and patient eligibility

About

The reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sJIA). Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive baricitinib or tocilizumab reference. In cohort 2, participants will receive baricitinib.

Enrollment: 58 estimated patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA) as defined by International League of Associations for Rheumatology (ILAR) criteria with onset before the age of 16 years
• Participants must have at least 2 active joints at screening and baseline
• Cohort 1 (IL-6 inhibitor therapy naive): Participants who are at least 1 year and less than 18 years of age, except in countries that restrict use of tocilizumab in participants less than 2 years of age
• Cohort 2 (open-label baricitinib): Participants who are at least 1 year and less than 18 years of age

Exclusion criteria

• Participants must not have polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis
• Participants must not have persistent oligoarticular arthritis as defined by the ILAR criteria
• Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA
• Participants must not have active anterior uveitis or are receiving concurrent treatment for anterior uveitis
• Participants must not have active fibromyalgia or other chronic pain conditions that, in the investigator's opinion, would make it difficult to appropriately assess disease activity for the purposes of this study
• Participants must not have biologic features of Macrophage Activation Syndrome (MAS) over the past 12 weeks
• Participants must not have a current or recent (<4 weeks prior to baseline) clinically serious infection
• Participants must not have a positive test for hepatitis B virus
• Participants must not have evidence of active tuberculosis (TB) or untreated latent TB

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 3 patient groups

Cohort 1 Baricitinib

Experimental group

Description:

Baricitinib given orally.

Treatment:

Drug: Baricitinib

Cohort 1 Tocilizumab

Active Comparator group

Description:

Tocilizumab given Subcutaneously (SC).

Treatment:

Drug: Tocilizumab

Cohort 2 Baricitinib

Experimental group

Description:

Baricitinib given orally.

Treatment:

Drug: Baricitinib